QA Incoming Inspector Ii

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Summary
- Inspects incoming materials and production processes to ensure compliance to customer specifications, GMP, pharmaceutical standards and internal SOP’s. Participates in pre-production planning activities, performs quality tests, conducts sampling, documents findings, tracks trends, etc.

Responsible for ensuring that components used in production meet the quality standards required by client. Monitors production for compliance to customer specifications, GMP, pharmaceutical standards and internal SOP’s. Performs line audits, final inspections as well as Line Clearance verifications. Responsible for pulling and labeling client requested samples (i.e., stability).

Essential Duties and Responsibilities:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.-
- Consistently applies company SOP’s relative to production, quality, and pharmaceutical standards.-
- Partners with Operations Personnel (i.e., Project Manager, Operations Manager, Production Supervisor, Warehouse Manager, Warehouse Associates) and Quality Assurance Personnel in judging product quality.-
- Conducts incoming material inspections and recommends the approval or rejection of the material.-
- Communicates material issues to Operations Personnel and Quality Assurance Personnel (i.e., Sr. QA Manager). Makes suggestions and aids where appropriate, to ensure production is expedited.-
- Generates in-house specifications for materials.-
- Acts as a line of communication between the Warehouse and the Sr. QA Manager.-
- Undertakes the writing, revision, and documentation of SOP’s.-
- Responsible for educating Operation Personnel (i.e., Warehouse Staff, Project Managers) in SOP’S.-
- Responsible for writing vendor complaints and ensuring that appropriate CAPAs are in place at the supplier/vendor site to address the issue.-
- Liaises with testing laboratories to ensure components are tested in a timely manner and results are reviewed against approved specifications.-
- Back up support to the various functions of the QA Team as required.-
- Responsible for monitoring and adherence to all PCI, Safety cGMP, and GCP policies, procedures, rules, including raising concerns or issues to the appropriate level.-
- Involved in start-up challenges and verification of correct lot/expiry date prior to start of the run.-
- Performs line audits during shift to ensure PBR and SOPs are being followed.-
- Conducts sampling routines.-
- Evaluates finished goods and recommends the approval or rejection of work accordingly.-
- Communicates issues and production problems to Operations Personnel and Quality Assurance Personnel. Makes suggestions and helps where appropriate, to ensure production is expedited.-
- Acts as a line of communication between the Packaging Rooms and the Compliance and QA Inspector Supervisor.-
- Assists in the investigation and resolution of quality problems.-
- Undertakes the writing, revision, and documentation of SOP’s.-
- Responsible for educating Operations Personnel (i.e., Production Supervisor, Line Leaders, Packagers and Mechanics) in SOP’S.-
- Assists the Compliance and QA Inspector Supervisor with the development of policies, procedures, and work practices.-
- Assists the Quality Director and Compliance and QA Inspector Supervisor with audits as requested.-
- Performs Line Clearances.-
- Responsible for approving completed logbook pages as required.-
- Checks and records room pressures on a daily basis-
- This position may require overtime and/or weekend work.-
- Attendance at work is an essential function of this position.-
- Responsible for other duties as required.Qualifications:
- University/college education in the fields of math, or science, or relevant practical experience.-
- Knowledge and experience with manufacturing processes and products.-
- Exceptional attention to detail and proofing ability.-
- Sound judgement when approving or rejecting work in keeping with specifications and internal quality control standards.-
- Effective interpersonal skills and the ability to influence and negotiate in the presentation of feedback to colleagues and superiors.-
- Computer knowledge to use software programs such as Access, Word, Excel, Internet, and custom company software, (ERP).-
- Excellent organizational, and time management skills to ensure deadlines are met.-
- Knowledge of GMP and pharmaceutical standards is an asset.Join us and be part of building the bridge between life changing therapies and patients.

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